Sign Out
The most common reported adverse reactions were gastrointestinal disorders which were mostly mild or moderate in severity.
The following adverse reactions have been observed during clinical trials with the indicated frequencies as follows. (See table.)
Click on icon to see table/diagram/imageStrictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations, see Precautions.
Allergic reactions mainly but not exclusively limited to the skin have been observed and been additionally identified as adverse reactions during post-approval use.
Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.
Paediatric population: No specific side effects were found. In children with cystic fibrosis frequency, type and severity of side effects were similar to those in adults.
View ADR Monitoring Form
